全部 标题 作者
关键词 摘要

OALib Journal期刊
ISSN: 2333-9721
费用:99美元

查看量下载量

AI-Powered NLP Framework for Extracting Drug Safety Information in Pregnancy

DOI: 10.4236/oalib.1113509, PP. 1-21

Subject Areas: Artificial Intelligence, Simulation/Analytical Evaluation of Communication Systems

Keywords: NLP, Drug Safety, Pregnancy, BERT, Transformer, Risk Classification, Clinical Decision Support, Trimester Analysis, Visualization, CANMAT, FDA, EMA

Full-Text   Cite this paper   Add to My Lib

Abstract

Pregnancy presents a unique clinical scenario where the safety of pharmacological interventions is of paramount importance. The potential teratogenic risks associated with drug intake during pregnancy necessitate a highly informed, evidence-based approach to prescribing. However, the rapid increase in published literature, clinical trials, and drug safety communications poses significant challenges for clinicians attempting to stay current with evolving data. To address this, we propose an AI-powered Natural Language Processing (NLP) framework designed to extract, interpret, and classify drug safety information from unstructured, pregnancy-related clinical texts. The system leverages transformer-based deep learning models—specifically fine-tuned variants of BERT—to classify drug risk levels into five categories: Safe, Low, Medium, High, and Unknown. Importantly, our approach integrates trimester-specific analysis to account for temporal variability in drug risk, a factor often overlooked in generalized models. The framework includes a visual analytics dashboard that supports confidence scoring, risk visualization, and interactive querying by trimester or drug class. Our model was trained and validated using annotated data derived from FDA labels, CANMAT guidelines, WHO publications, and peer-reviewed case reports. Validation results demonstrate high precision in identifying clear-cut cases (e.g., Paracetamol as Safe; Warfarin as High risk) and meaningful generalization across unseen data. A functional prototype has been developed that supports clinicians in making real-time, literature-informed prescribing decisions. Ultimately, this research contributes to safer pharmacotherapy in pregnancy by providing a scalable, explainable, and clinically relevant AI tool. It serves as both a foundation for future research and a practical application for healthcare decision support.

Cite this paper

Filippis, R. D. and Foysal, A. A. (2025). AI-Powered NLP Framework for Extracting Drug Safety Information in Pregnancy. Open Access Library Journal, 12, e3509. doi: http://dx.doi.org/10.4236/oalib.1113509.

References

[1]  Erdeljić, V., Francetić, I., Makar-Aušperger, K., Likić, R. and Radačić-Aumiler, M. (2010) Clinical Pharmacology Consultation: A Better Answer to Safety Issues of Drug Therapy during Pregnancy? European Journal of Clinical Pharmacology, 66, 1037-1046. https://doi.org/10.1007/s00228-010-0867-5
[2]  van Donge, T., Evers, K., Koch, G., van den Anker, J. and Pfister, M. (2019) Clinical Pharmacology and Pharmacometrics to Better Understand Physiological Chang-es during Pregnancy and Neonatal Life. In: Kiess, W., Schwab, M. and van den Anke, J., Eds., Handbook of Experimental Pharmacology, Springer International Publishing, 325-337. https://doi.org/10.1007/164_2019_210
[3]  Lydon-Rochelle, M.T., Holt, V.L., Cárdenas, V., Nelson, J.C., Easterling, T.R., Gardella, C., et al. (2005) The Re-porting of Pre-Existing Maternal Medical Conditions and Complications of Pregnancy on Birth Certificates and in Hospital Discharge Data. American Jour-nal of Obstetrics and Gynecology, 193, 125-134. https://doi.org/10.1016/j.ajog.2005.02.096
[4]  Singh, H., Murphy, H.R., Hendrieckx, C., Ritterband, L. and Speight, J. (2013) The Challenges and Future Considerations Regarding Pregnancy-Related Outcomes in Women with Pre-Existing Diabetes. Current Diabetes Reports, 13, 869-876. https://doi.org/10.1007/s11892-013-0417-5
[5]  Stergiopoulos, K., Shiang, E. and Bench, T. (2011) Pregnancy in Patients with Pre-Existing Cardiomyopa-thies. Journal of the American College of Cardiology, 58, 337-350. https://doi.org/10.1016/j.jacc.2011.04.014
[6]  Walkinshaw, S.A. (2005) Pregnancy in Women with Pre-Existing Diabetes: Management Issues. Seminars in Fetal and Neonatal Medicine, 10, 307-315. https://doi.org/10.1016/j.siny.2005.04.004
[7]  Jost, E., Kosian, P., Greiner, G.G., Icks, A., Schmitz, M., Schmid, M., et al. (2024) Obstetric Medicine: The Protocol for a Prospective Three-Dimensional Cohort Study to Assess Maternity Care for Women with Pre-Existing Conditions (Format). Frontiers in Medicine, 10, Article 1258716. https://doi.org/10.3389/fmed.2023.1258716
[8]  Hendriks, S., Grady, C., Wasserman, D., Wendler, D., Bianchi, D.W. and Berkman, B.E. (2021) A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials. The American Journal of Bioethics, 22, 45-61. https://doi.org/10.1080/15265161.2020.1867932
[9]  Raffaelli, B., Ru-bio-Beltrán, E., Cho, S., De Icco, R., Labastida-Ramirez, A., Onan, D., et al. (2023) Health Equity, Care Access and Quality in Headache—Part 2. The Jour-nal of Headache and Pain, 24, Article No. 167. https://doi.org/10.1186/s10194-023-01699-7
[10]  Krewski, D. (2022) De-velopment of an Evidence-Based Risk Assessment Framework. ALTEX, 39, 667-693. https://doi.org/10.14573/altex.2004071
[11]  Mt-Isa, S.H. (2011) Improving Evidence-Based Risk-Benefit Decision-Making of Medicines for Chil-dren. Ph.D. Dissertation, School of Public Health, Imperial College Lon-don.
[12]  Mussen, F., Salek, S. and Walker, S. (2008) Benefit‐Risk Appraisal of Medicines. John Wiley & Sons. https://doi.org/10.1002/9780470748114
[13]  Esposito and Giovanna (2024) Reproduction and Childbearing Health: Re-Al-World Evidence from Administrative Databases.
[14]  Namazy, J., Chambers, C., Sahin, L., Johnson, T., Dinatale, M., Lappin, B., et al. (2020) Clinicians’ Perspective of the New Pregnancy and Lactation Labeling Rule (PLLR): Results from an AAAAI/FDA Survey. The Journal of Allergy and Clinical Immunology: In Practice, 8, 1947-1952. https://doi.org/10.1016/j.jaip.2020.01.056
[15]  Byrne, J.J., Saucedo, A.M. and Spong, C.Y. (2020) Evaluation of Drug Labels Following the 2015 Pregnancy and Lactation Labeling Rule. JAMA Network Open, 3, e2015094. https://doi.org/10.1001/jamanetworkopen.2020.15094
[16]  Wicks, S., Tib-bets, J., Caruso, E., et al. (2024) Assessing US Food and Drug Administration Authorities, Guidance, and Policies for Prescription Drug, Biological Product, and Medical Device Development and Commercialization for Use by Pregnant and Lactating Women. Advancing Clinical Research, 54 p.
[17]  Sharma, V., Sharma, P. and Sharma, S. (2020) Managing Bipolar Disorder during Pregnan-cy and the Postpartum Period: A Critical Review of Current Practice. Expert Re-view of Neurotherapeutics, 20, 373-383. https://doi.org/10.1080/14737175.2020.1743684
[18]  Amosa, T.I., Izhar, L.I.B., Sebastian, P., Ismail, I.B., Ibrahim, O. and Ayinla, S.L. (2023) Clinical Er-rors from Acronym Use in Electronic Health Record: A Review of NLP-Based Disambiguation Techniques. IEEE Access, 11, 59297-59316. https://doi.org/10.1109/access.2023.3284682
[19]  Egger, J., Gsaxner, C., Pepe, A., Pomykala, K.L., Jonske, F., Kurz, M., et al. (2022) Medical Deep Learning—A Systematic Meta-Review. Computer Methods and Programs in Bi-omedicine, 221, Article 106874. https://doi.org/10.1016/j.cmpb.2022.106874
[20]  van Dinter, R., Tekiner-dogan, B. and Catal, C. (2021) Automation of Systematic Literature Reviews: A Systematic Literature Review. Information and Software Technology, 136, Arti-cle 106589. https://doi.org/10.1016/j.infsof.2021.106589
[21]  Chaudhury, A., Ward, C., Talasaz, A., Ivanov, A.G., Huner, N.P.A., Grodzinski, B., et al. (2015) Computer Vision Based Autonomous Robotic System for 3D Plant Growth Measurement. 2015 12th Conference on Computer and Robot Vision, Halifax, 3-5 June 2015, 290-296. https://doi.org/10.1109/crv.2015.45
[22]  Ahire, Y.S., Patil, J.H., Chordiya, H.N., Deore, R.A. and Bairagi, V.A. (2024) Advanced Applications of Artificial Intelligence in Pharmacovigilance: Current Trends and Future Perspectives. Journal of Pharmaceutical Research, 23, 23-33. https://doi.org/10.18579/jopcr/v23.1.24
[23]  Dimitra, P. (2018) The Knowledge Discovery Cube Framework A Reference Framework for Collabora-tive, Information-Driven Pharmacovigilance. University of Surrey (United Kingdom).
[24]  Sivathapandi, P. (2022) Advanced AI Algorithms for Auto-mating Data Preprocessing in Healthcare: Optimizing Data Quality and Reducing Processing Time. Journal of Science & Technology, 3, 126-167.
[25]  Monlezun, D.J. (2024) Our Common Home: Artificial Intelligence Global Public Health Ecosystem. In: Monlezun, D.J., Ed., Responsible Artificial Intelligence Re-Engineering the Global Public Health Ecosystem, Elsevier, 215-243. https://doi.org/10.1016/b978-0-443-21597-1.00007-x
[26]  Foulkes, M. (2015) Development of the Maternal-Fetal Relationship in Women Who Use Substances: Understanding the Influence of Intersecting Variables on Mater-nal-Fetal Attachment and Health Behaviours. Ph.D. Dissertation, University of Ottawa.
[27]  Smid, M., Bourgois, P. and Auerswald, C.L. (2010) The Challenge of Pregnancy among Homeless Youth: Reclaiming a Lost Opportunity. Journal of Health Care for the Poor and Underserved, 21, 140-156. https://doi.org/10.1353/hpu.0.0318
[28]  Poon, L.C., Shennan, A., Hyett, J.A., Kapur, A., Hadar, E., Divakar, H., et al. (2019) The International Federation of Gynecology and Obstetrics (FIGO) Initiative on Pre‐eclampsia: A Pragmatic Guide for First‐Trimester Screening and Prevention. International Journal of Gynecology & Obstetrics, 145, 1-33. https://doi.org/10.1002/ijgo.12802
[29]  Tacy, T.A., Kasparian, N.A., Karnik, R., Geiger, M. and Sood, E. (2022) Opportunities to Enhance Parental Well-Being during Prenatal Counseling for Congenital Heart Disease. Seminars in Perinatology, 46, Article 151587. https://doi.org/10.1016/j.semperi.2022.151587
[30]  Suter, S.M. (2002) The Routinization of Prenatal Testing. American Journal of Law & Medicine, 28, 233-270. https://doi.org/10.1017/s0098858800011655
[31]  Wilson, L. (2024) Enhancing Safety Surveillance during Clinical Trials: The Development of a Safety Data Review Handbook to Support Pharmacovigilance Clinicians. University of New Hampshire.
[32]  Ryan, P.B., Schuemie, M.J., Welebob, E., Duke, J., Valentine, S. and Hartzema, A.G. (2013) Defining a Reference Set to Support Methodological Research in Drug Safety. Drug Safety, 36, 33-47. https://doi.org/10.1007/s40264-013-0097-8
[33]  Hong, Y.D., Jansen, J.P., Guerino, J., Berger, M.L., Crown, W., Goettsch, W.G., et al. (2021) Comparative Effectiveness and Safety of Pharmaceuticals Assessed in Observational Studies Compared with Randomized Controlled Trials. BMC Medicine, 19, Article No. 307. https://doi.org/10.1186/s12916-021-02176-1
[34]  Sundaram, G. and Berleant, D. (2023) Automating Systematic Literature Reviews with Natural Language Processing and Text Mining: A Systematic Literature Review. In: Yang, R., Sherratt, S. Dey, N. and Joshi, A., Eds., International Congress on Information and Communication Technology, Springer, 73-92.
[35]  Dreisbach, C., Koleck, T.A., Bourne, P.E. and Bakken, S. (2019) A Systematic Review of Natural Lan-guage Processing and Text Mining of Symptoms from Electronic Pa-tient-Authored Text Data. International Journal of Medical Informatics, 125, 37-46. https://doi.org/10.1016/j.ijmedinf.2019.02.008
[36]  Sawicki, J., Gan-zha, M. and Paprzycki, M. (2023) The State of the Art of Natural Language Processing—A Systematic Automated Review of NLP Literature Using NLP Techniques. Data Intelligence, 5, 707-749. https://doi.org/10.1162/dint_a_00213
[37]  Ofori-Boateng, R., Aceves-Martins, M., Wiratunga, N. andMoreno-Garcia, C.F. (2024) Towards the Automation of Systematic Reviews Using Natural Language Processing, Machine Learning, and Deep Learning: A Comprehensive Review. Artificial Intelligence Review, 57, Ar-ticle No. 200.
[38]  Allam, H., Makubvure, L., Gyamfi, B., Graham, K. and Akinwolere, K. (2025) Text Classification: How Machine Learning Is Revolution-izing Text Categorization. Information, 16, 130.
[39]  Hu, Z., Dychka, I., Pota-pova, K. and Meliukh, V. (2024) Augmenting Sentiment Analysis Prediction in Binary Text Classification through Advanced Natural Language Processing Mod-els and Classifiers. International Journal of Information Technology and Com-puter Science, 16, 16-31. https://doi.org/10.5815/ijitcs.2024.02.02
[40]  Han, H., Asif, M., Awwad, E.M., Sarhan, N., Ghadi, Y.Y. and Xu, B. (2024) Innovative Deep Learning Tech-niques for Monitoring Aggressive Behavior in Social Media Posts. Journal of Cloud Computing, 13, Article No. 19. https://doi.org/10.1186/s13677-023-00577-6
[41]  Nerella, S., Bandyo-padhyay, S., Zhang, J., Contreras, M., Siegel, S., et al. (2023) Transformers in Healthcare: A Survey. arXiv preprint arXiv:2307.00067.
[42]  Cho, H.N., Jun, T.J., Kim, Y., Kang, H., Ahn, I., Gwon, H., et al. (2024) Task-Specific Transform-er-Based Language Models in Health Care: Scoping Review. JMIR Medical In-formatics, 12, e49724. https://doi.org/10.2196/49724
[43]  Rodrıguez, H. (2022) Natural Language Technologies in the Biomedical Domain. In: Bacciu, D., Lisboa, P.J.G. and Vellido, A., Eds., Deep Learning in Biology and Medicine, World Scientific Connect, 93-130.
[44]  Bose, P., Srinivasan, S., Sleeman, W.C., Palta, J., Kapoor, R. and Ghosh, P. (2021) A Survey on Recent Named Entity Recognition and Relationship Extraction Techniques on Clinical Texts. Applied Sciences, 11, Article 8319. https://doi.org/10.3390/app11188319
[45]  Lei, J., Tang, B., Lu, X., Gao, K., Jiang, M. and Xu, H. (2014) A Comprehensive Study of Named Entity Recognition in Chinese Clinical Text. Journal of the American Medical Informatics Association, 21, 808-814. https://doi.org/10.1136/amiajnl-2013-002381
[46]  Liu, Z., Yang, M., Wang, X., Chen, Q., Tang, B., Wang, Z., et al. (2017) Entity Recognition from Clinical Texts via Recurrent Neural Network. BMC Medical Informatics and Decision Making, 17, Article No. 67. https://doi.org/10.1186/s12911-017-0468-7
[47]  Fraile Navarro, D., Ijaz, K., Rezazadegan, D., Rahimi-Ardabili, H., Dras, M., Coiera, E., et al. (2023) Clinical Named Entity Recognition and Relation Extraction Using Natural Language Pro-cessing of Medical Free Text: A Systematic Review. International Journal of Medical Informatics, 177, Article 105122. https://doi.org/10.1016/j.ijmedinf.2023.105122
[48]  Vithanage, D., Yu, P., Wang, L. and Deng, C. (2024) Contextual Word Embedding for Biomedical Knowledge Extraction: A Rapid Review and Case Study. Journal of Healthcare Informatics Research, 8, 158-179. https://doi.org/10.1007/s41666-023-00157-y
[49]  Si, Y., Wang, J., Xu, H. and Roberts, K. (2019) Enhancing Clinical Concept Extraction with Contextual Embeddings. Journal of the American Medical Informatics Association, 26, 1297-1304. https://doi.org/10.1093/jamia/ocz096
[50]  Wood, M.E., An-drade, S.E. and Toh, S. (2019) Safe Expectations: Current State and Future Di-rections for Medication Safety in Pregnancy Research. Clinical Therapeutics, 41, 2467-2476. https://doi.org/10.1016/j.clinthera.2019.08.016
[51]  Menon, R., Richardson, L. and Kammala, A.K. (2024) New Approach Methods on the Bench Side to Accelerate Clinical Trials during Pregnancy. Expert Opinion on Drug Metabolism & Toxicology, 20, 555-560. https://doi.org/10.1080/17425255.2024.2353944
[52]  Cao, H., Oghene-maro, E.F., Latypova, A., Abosaoda, M.K., Zaman, G.S. and Devi, A. (2025) Ad-vancing Clinical Biochemistry: Addressing Gaps and Driving Future Innovations. Frontiers in Medicine, 12, Article 1521126. https://doi.org/10.3389/fmed.2025.1521126
[53]  Dolk, H., Damase‐Michel, C., Morris, J.K. and Loane, M. (2022) COVID‐19 in Pregnancy—What Study De-signs Can We Use to Assess the Risk of Congenital Anomalies in Relation to COVID‐19 Disease, Treatment and Vaccination? Paediatric and Perinatal Epi-demiology, 36, 493-507. https://doi.org/10.1111/ppe.12840
[54]  Borda, L.A., Någård, M., Boulton, D.W., Venkataramanan, R. and Coppola, P. (2023) A Systematic Review of Pregnancy-Related Clinical Intervention of Drug Regimens Due to Pharmacokinetic Reasons. Frontiers in Medicine, 10, Article 1241456. https://doi.org/10.3389/fmed.2023.1241456
[55]  Rezaallah, B. (2019) Pharmacovigilance of Pregnancy Exposures to Medicinal Products Focusing on the Risk of Orofacial Clefts. Ph.D. Dissertation, University of Ba-sel.
[56]  D’Amore, F.M., Moscatelli, M., Malvaso, A., D’Antonio, F., Rodini, M., Panigutti, M., et al. (2025) Explainable Machine Learning on Clinical Features to Predict and Differentiate Alzheimer’s Progression by Sex: Toward a Clini-cian-Tailored Web Interface. Journal of the Neurological Sciences, 468, Article 123361. https://doi.org/10.1016/j.jns.2024.123361
[57]  El Arab, R.A., Al-moosa, Z., Alkhunaizi, M., Abuadas, F.H. and Somerville, J. (2025) Artificial In-telligence in Hospital Infection Prevention: An Integrative Review. Frontiers in Public Health, 13, Article 1547450. https://doi.org/10.3389/fpubh.2025.1547450
[58]  Lambert, M.J., Whipple, J.L. and Kleinstäuber, M. (2018) Collecting and Delivering Progress Feedback: A Meta-Analysis of Routine Outcome Monitoring. Psychotherapy, 55, 520-537. https://doi.org/10.1037/pst0000167
[59]  Koroteev and Mikhail, V. (2021) BERT: A Review of Applications in Natural Language Processing and Under-standing. arXiv preprint arXiv:2103.11943.
[60]  Kalusivalingam, K.A., Shar-ma, A., Patel, N. and Singh, V. (2021) Leveraging BERT and LSTM for Enhanced Natural Language Processing in Clinical Data Analysis. International Journal of AI and ML, 2, 1-24.
[61]  Devlin, J., Chang, M., Lee, K. and Toutanova, K. (2019) Bert: Pre-Training of Deep Bidirectional Transformers for Language Understanding. Proceedings of the 2019 Conference of the North American Chapter of the Association for Computational Linguistics: Human Language Technologies, 1 4171-4186.
[62]  Lavecchia, A. (2024) Advancing Drug Dis-covery with Deep Attention Neural Networks. Drug Discovery Today, 29, Article 104067. https://doi.org/10.1016/j.drudis.2024.104067
[63]  ValizadehAslani, T., Shi, Y., Ren, P., Wang, J., Zhang, Y., Hu, M., et al. (2023) PharmBERT: A Do-main-Specific BERT Model for Drug Labels. Briefings in Bioinformatics, 24, bbad226. https://doi.org/10.1093/bib/bbad226
[64]  Kristina M., D., Byatt, N. and Marlene P., F. (2014) Pharmacotherapy for Mood Disorders in Preg-nancy: A Review of Pharmacokinetic Changes and Clinical Recommendations for Therapeutic Drug Monitoring. Journal of Clinical Psychopharmacology, 34, 244-255. https://doi.org/10.1097/JCP.0000000000000087
[65]  Pariente, G., Leibson, T., Carls, A., Adams-Webber, T., Ito, S. and Koren, G. (2016) Preg-nancy-Associated Changes in Pharmacokinetics: A Systematic Review. PLOS Medicine, 13, e1002160. https://doi.org/10.1371/journal.pmed.1002160

Full-Text


Contact Us

service@oalib.com

QQ:3279437679

WhatsApp +8615387084133